Some smaller cigarette manufacturers have sued FDA to invalidate a provision in FDA’s recently issued final rule that would restrict a manufacturer from using certain product names on the ground that the restriction violates the First and Fifth Amendments, among other grounds. Section 1140.16(a) of FDA’s final rule restricting the sale and distribution of cigarettes and smokeless tobacco to minors restricts a manufacturer from using the trade or brand name of a nontobacco product as the trade or brand name for a cigarette or smokeless tobacco product, unless the trade or brand name was on both a tobacco product and a nontobacco product sold in the U.S. on January 1, 1995. Products that violate the restriction are deemed misbranded.

The manufacturers contend that the restriction has a disproportionate negative impact on small cigarette manufacturers because the trade or brand names used by the larger manufacturers are generally excepted by virtue of having been in use prior to 1995. As examples of the restriction’s far-reaching effects, the complaint cites (among other things) the fact that the restriction:

applies even where the manufacturer of the nontobacco and the tobacco products are wholly unrelated;

the nature of the products is such that there is no likelihood of confusion, mistake, or deception;

no account is taken of whether different geographic markets are in play;

the restriction applies regardless of which product had first use and trademark registration; and

the rule includes no grandfather clause, such that a name used well before the rule’s effective date (but after January 1, 1995) would nonetheless be restricted.

Plaintiff’s contend that the rule would result in a loss of commercial speech, as well as a taking and destruction of property interests, in violation of the First and Fifth Amendments. Plaintiffs seek both a preliminary and permanent injunction, as well as other relief.